The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.

The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]

The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) - 5] * 4.

The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males and Females 18-65 years old

VEINES Sym Score less than 75 points

Varicose Vein clinical classification CEAP 2, 3, 4, or 5

Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein

Superficial venous disease manifested by both symptoms and visible varicosities

Ability to comprehend and sign an informed consent document and completed study questionnaires in English

Exclusion Criteria:

Incompetence of the SSV which substantially contributes to the filling of visible varicose veins

Current or previous Deep Vein Thrombosis

Leg obesity

Peripheral arterial disease in the leg to be treated

Reduced mobility

Planned prolonged travel with limited mobility with in 4 weeks of treatment

History of pulmonary embolism or stroke

Major surgery, prolonged hospitalization or pregnancy within 3 months

Current anticoagulation therapy (within 7 days of enrollment)

Participation in a clinical study involving a investigational product within 3 months

Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions

Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study

Pregnant or lactating women

Current alcohol or drug abuse

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758420